Design, data monitoring, and analysis of clinical trials with co-primary endpoints: A review.

Toshimitsu HamasakiScott R EvansKoko Asakura

Published in: Journal of biopharmaceutical statistics (2017)

We review the design, data monitoring, and analyses of clinical trials with co-primary endpoints. Recently developed methods for fixed-sample and group-sequential settings are described. Practical considerations are discussed, and guidance for the application of these methods is provided.

Keyphrases

clinical trial
electronic health record
big data
phase ii
randomized controlled trial
open label
phase iii
deep learning